This invention is concerned with anti-smoking oral preparations containing silver compounds.
In recent times many studies conducted on the effects of smoking on human health have demonstrated that smoking is a health-threatening and life-threatening habit. Studies have also indicated that cessation of smoking can significantly ameliorate, if not eliminate, the adverse effects of tobacco smoking. The public awareness of the hazards of smoking and the benefits of quitting have spawned products and methods to aid the smoker in breaking the habit.
Silver salts have been used as anti-smoking agents because of their unpleasant taste which becomes accentuated when in contact with tobacco smoke. However, they cause an unpleasant taste in the mouth even in the absence of tobacco smoke and spoil the flavor of food and drink. They are also absorbed by the body and on prolonged use cause a permanent condition of the skin known as argyria which is a greyish or even black pigmentation of the skin.
In an effort to promote the anti-smoking characteristics of silver salts the art has employed methods to attenuate their toxic side effects.
For example, in U.S. Pat. No. 3,876,804 to D. Woodcraft an anti-smoking chewing gum is described containing a silver compound in which the silver is bound in complex form or a silver compound and a compound which in its dissolved state forms ions with silver to form silver complex ions. Such gum, in its preferred form, comprises silver acetate, a complexing agent such as ammonium chloride and a salivary promoter such as a co-carboxylase. Purportedly the gums overcome the disadvantages of silver salts by (a) masking the unpleasant taste of silver ions by complexing while still providing an unpleasant taste during smoking; and (b) effecting slow release of the active ingredient so that the user is not subjected to sudden high concentrations of silver salts which would occur on using a tablet, for example.
Commercial anti-smoking oral preparations as used today such as chewing gums and lozenges employ about 6 mg. of silver salt or compound and that level of silver has been deemed the quantity which will effectively raise the unpleasant bitter taste during smoking in the user while at the same time not be of such a magnitude to render the preparation toxic. An advisory review panel of the Food and Drug Administration (FDA) has even recommended a proposed dose of up to 6 mg. of silver acetate in a chewing gum every four hours but not more than 6 such doses in a 24 hour period. The gum was not to be used for more than 3 weeks.
It has now been found, according to the present invention, that it is not necessary to obtain an effective bitter taste response as a smoking deterrent using a silver compound such as silver acetate in amounts of 6 mg. or more and that complexing of such silver compounds using ammonium salts or amines is also unnecessary for taste masking or the reduction of toxicity. According to the present invention, an effective smoking deterrent response is accomplished by delivering to the mouth a small, but uniform concentration of silver ions at or within 1 to 2 hours of smoking. By employing a sweetener rather than a complexing agent in an anti-smoking oral composition the bitter taste of silver ions is substantially eliminated and the effective silver concentration necessary to provide smoking deterrence can be reduced dramatically thus reducing cost as well as the danger of toxic side effects.